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PREGNANCY AND INFANT OUTCOMES FOLLOWING IN UTERO EXPOSURE TO JAK INHIBITORS IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A GLOBAL MULTICENTER COHORT STUDY

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PREGNANCY AND INFANT OUTCOMES FOLLOWING IN UTERO EXPOSURE TO JAK INHIBITORS IN WOMEN WITH INFLAMMATORY BOWEL DISEASE: A GLOBAL MULTICENTER COHORT STUDY

Mette Julsgaard 1, Simon Mark Dahl Baunwall 2, Cynthia Seow 3, Dana Duricova 4, Sunanda Kane 5, Neha Zacharias 6, Rupert W Leong 7, Bel Klaartje Kok 8, Anna Kagramanova 9, Barbora Pipek 10, Kristina Candido 11, Rachel Cooney 12, Rafal Filip 13, Vytautas Kiudelis 14, Michal Konecny 15, Daniela Pugliese 16, Genoile Silva 17, Edoardo Vincenzo Savarino 18, Brigita Smolovic 19, Sophie Vieujean 20, Shu-Chen Wei 21, Uma Mahadevan 22

Affiliations

1 Aarhus University Hospital, Aarhus N, Denmark|||Aarhus University, Aarhus N, Denmark

2 Aarhus University Hospital, Aarhus N, Denmark

3 University of Calgary, Calgary, Canada

4 ISCARE I.V.F. a.s., Prague, Czechia

5 Mayo Clinic, Rochester, Rochester, United States

6 Hull University Teaching Hospitals, Hull, United Kingdom

7 Concord Repatriation General Hospital, Sydney, Australia|||Macquarie University, Sydney, Australia

8 Barts Health NHS Trust, London, United Kingdom

9 A. S. Loginov Moscow Clinical Scientific Center, Moscow, Balaschiha, Russian Federation|||Research Institute of Health Organization and Medical Management, Moscow, Russian Federation

10 Faculty of Medicine and Dentistry, Palacky University and University Hospital, Olomouc, Czechia|||Hospital AGEL Vitkovice, Ostrava, Czechia

11 McGill University, Montreal, Canada

12 University Hospital Birmingham NHS Trust, Birmingham, United Kingdom

13 Regional Hospital No. 2 in Rzeszow, Rzeszów, Poland|||University of Rzeszow, Rzeszow, Poland

14 Lithuanian University of Health Sciences, Kaunas, Lithuania

15 Palacky University and University Hospital Olomouc, Olomouc, Czechia

16 Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy|||Università Cattolica del Sacro Cuore, Rome, Italy

17 Universidade do Estado da Bahia, Salvador, Bahia, Brazil

18 University of Padua, Division of Gastroenterology, Padua, Italy

19 Faculty of Medicine, University of Montenegro, Podgorica, Montenegro

20 University Hospital CHU of Liège, Liège, Belgium

21 National Taiwan University Hospital, Taipei City, Taiwan, Province of China

22 University of California, San Francisco, United States

Summary

AI Generated

In a global multicenter retrospective study of 43 JAK inhibitor-exposed pregnancies in women with IBD, maternal complication rates were low and no congenital abnormalities were observed among 35 live births, with reassuring infant outcomes including normal development and no adverse vaccine responses.

Among 35 live births, no congenital abnormalities were reported, with 1 preterm infant (2.9%), 3 small for gestational age (8.6%), and 1 with Apgar score less than 7 at 5 minutes (2.9%).
Maternal complications were low with no cases of DVT or preeclampsia, though 3 cases of premature rupture of membranes (GA 34-37) and 4 hospitalizations for infection or other complications occurred.
Disease activity was present in 51.2% of pregnancies, and among women who discontinued JAK inhibitors in the first or second trimester, 63.6% experienced disease flare.
Follow-up of 31 infants (median 17 months, range 1-88) showed 100% normal development, with no adverse effects reported following live BCG, rotavirus, or MMR vaccines.
Two infants (6.5%) required hospitalization for infection at age 0-4 months, both born to mothers with moderate-to-severe disease activity treated with systemic corticosteroids and upadacitinib initiated during pregnancy, with no infection-related sequelae.
Among 24 breastfeeding women, 29.2% continued JAK inhibitor treatment during lactation.

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Abstract

Introduction

JAK inhibitors (JAKi) are small molecules capable of crossing the placenta via passive diffusion or active extracellular transport from early pregnancy.¹ Data on the risks of in utero JAKi exposure are limited,² particularly regarding pregnancy outcomes, infant infections, vaccine responses, and childhood development.

Aims & Methods

We conducted a multicenter retrospective JAKi and pregnancy observational study supported by the ECCO Collaborative Network for Exceptionally Rare Case Reports (CONFER). Pregnant women with inflammatory bowel disease (IBD) exposed to tofacitinib (TOFA), upadacitinib (UPA), or filgotinib (FILGO) during pregnancy were enrolled from 21 centers across 15 countries. Data collected included maternal demographics, IBD characteristics, disease activity, medication use - including timing and duration of JAKi exposure - along with maternal, pregnancy, and infant outcomes.

Results

Of 43 JAKi exposed pregnancies, 17 (39.5%) were unplanned. Disease activity was present in 22 (51.2%) of the pregnancies. One-in-five women initiated JAKi in pregnancy (n=8, 18.6%). Abortion occurred in 8 cases, at a median gestational age (GA) of 8.5 weeks (range 3-16). Of these, 3 (7.0%) were spontaneous and 5 (11.6%) induced, with two terminations due to concerns about potential adverse effects of JAKi treatment. Of the remaining 35 pregnancies 26 (74.3%) were exposed to TOFA (5 mg BID (n=9), 10 mg BID (n=17)), 8 (22.9%) to UPA (30 mg daily (n=2), 45 mg daily (n=6)) and one (2.9%) to FILGO (200 mg daily). The majority received JAKi treatment throughout pregnancy (n=24, 68.6%). Discontinuation of JAKi during the 1^st or 2^nd trimester was followed by disease activity in 7 of 11 cases (63.6%). Maternal complication risk was low: no cases of DVT or (pre)eclampsia; premature rupture of membranes (GA 34–37) occurred in 3 cases, and 4 women required hospitalization due to infection or other complications. Among 35 live births, one infant (2.9%) was preterm (GA 34), three (8.6%) were small for gestational age, one (2.9%) had an Apgar score <7 at 5 minutes, and no congenital abnormalities were reported. Follow-up infant data are shown in table 1. One-third of breastfeeding women continued JAKi treatment. A high adherence rate to the national immunization schedule was seen. Three (8.6%) skipped the live rotavirus vaccine due to in uteroJAKi exposure. No adverse effects were reported following live attenuated or inactivated vaccines, and no malignancies were observed.

Table 1. Follow-up in 31 infants after in utero exposure to JAK-inhibitors
	n	(%)	Notes
Duration, months – median (range)	17	(1-88)
Proportion of breastfeeding women (n=24) who continued JAKi treatment	7	(29.2)
Infection resulting in hospitalization (age 0-4 months)	2	(6.5)	Moderate-to-severe maternal disease activity treated with systemic corticosteroids and initiation of upadacitinib at gestational weeks 8 and 28, respectively. No infection-related sequelae.
Normal development	31	(100)
Follow the national immunization program	26	(74.3)
Live BCG vaccine provided (age 0-1 month)	5	(16.1)	No adverse effects reported.
Live Rotavirus vaccine provided (age 1.5-6 months)	13	(41.9)	No adverse effects reported.
Live MMR vaccine provided (age ≥ 12 months)	13	(41.9)	No adverse effects reported.

Conclusion

In this global multicenter study of JAKi exposure during pregnancy in women with IBD, maternal complication rates were low, and no increased risk of adverse pregnancy outcome were observed among live births. While disease activity was common, particularly following early discontinuation of JAKi, infant outcomes - including development, infection risk, and vaccine response - were reassuring. These findings provide important preliminary safety data to guide decision-making regarding the use of JAKi in pregnancy, though further prospective studies are needed to confirm long-term safety.

References

1. Fein KC, Arral ML, Kim JS, et al. Placental drug transport and fetal exposure during pregnancy is determined by drug molecular size, chemistry, and conformation. J Control Release 2023;361:29-39.
2. Torres J, Chaparro M, Julsgaard M, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis 2023;17:1-27.

Disclosure

M. Julsgaard: Advisory board for AbbVie. G. Santana: Speaker and advisory board for pfizer.

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine

Submission format

Abstract

Session

Clinical management of IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

Fistulising Crohn's disease: Underlying mechanism

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LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Ian White

UEG Presentation

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ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

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ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Krisztina Barbara Gecse 1, Joep van Oostrom 1, Svend T. Rietdijk 2, Svein Oskar Frigstad 3, Glen A Doherty 4, Peter Irving 5, David Laharie 6, Floris de Voogd 1, Maarten Pruijt 1, Suzanne Anjie 1, Lotte Oldenburg 1, Adriaan Volkers 1, Lieven Mulders 1, Rossana de la Croix-Vingerling 2, Renza Koppes 2, Md Monirul Islam 3, Kristin Hammersboen Bjorlykke 7, Kine Haug 7, Carolann Coe 4, Diane Mould 8, John James 8, Chris Moore 9, Melanie Hulshoff 1, Mark Lowenberg 1, Andra Neefjes-Borst 1, Ron Mathôt 1, Esmé Clasquin 1, Kristin Kaasen Jørgensen 10, Sunny Gurm 11, Michael Byrne 11, Geert R. D'Haens 1

Affiliations

1 Amsterdam University Medical Center, Amsterdam, Netherlands

2 Onze Lieven Vrouwen Gasthuis, Amsterdam, Netherlands

3 Vestre Viken HF, Gjettum, Norway

4 University College Dublin, School of Medicine, St Vincent's Hospital, Dublin, Ireland

5 Guy´s and St Thomas´ Hospital, London, United Kingdom

6 Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

7 Akershus Universitetssykehus, Nordbyhagen, Norway

8 Baysient LLC, Fort Meyers, United States

9 BÜHLMANN Laboratories AG, Basel, Switzerland

10 Akershus Universitetssykehus, Faculty of Medicine, University of Oslo, Nordbyhagen, Norway

11 Dova Health Intelligence, Vancouver, Canada

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Abstract

Introduction

Up to 40% of patients with acute severe ulcerative colitis (ASUC) do not respond to infliximab (IFX)(1) presumably due to insufficient drug exposure (1, 2). We investigated whether personalised IFX induction using predefined serum concentrations was superior to standard dosing.

Aims & Methods

In this prospective, multi-centre trial, adult IFX-naive steroid-refractory ASUC patients were randomised 1:1 to standard (SD) or personalised IFX dosing (PD). After an initial 5 mg/kg IFX infusion, SD was 5 mg/kg IFX at week 2 and 6. In PD, additional 5 mg/kg IFX infusions were administered guided by a Bayesian pharmacokinetic algorithm (iDose™) aiming at IFX serum concentrations >28 ug/mL day 0-28 and >15 ug/mL day 29-42 (3). The primary composite endpoint was clinical and endoscopic response at day 42 (Lichtiger score <10 and ≥3 points drop and UCEIS ≥2 points drop from baseline). Video-endoscopies were performed at baseline, day 42 and 182 and scored by 2 expert readers (XR) with adjudication by a third XR and post hoc also by the DovaVision UC AI tool (AI-R)(4). Key secondary endpoints were day 42 clinical response, day 42 endoscopic response, day 182 clinical remission (Lichtiger ≤3), day 182 endoscopic remission (UCEIS ≤1 on all components), and safety.

Results

48 patients were randomised (23 PD/25 SD) and 31 completed the 26-week study (19 PD/12 SD). Patient characteristics were comparable. Median cumulative IFX dose until day 42 was 18.41 mg/kg [1.77, 20.27] for PD vs 13.79 mg/kg [10.38, 14.82] for SD. The primary composite endpoint at day 42 was not met with XR (57% in PD vs 44% in SD; p=0.564). However, AI-R showed a significantly higher composite response rate in PD (74% in PD vs 32% in SD; p=0.0047). PD showed higher day 42 clinical response vs SD (91% vs 64%; p=0.039). Day 42 endoscopic response was observed in 57% in PD vs 44% in SD (p=0.564) with XR and 74% in PD vs 32% in SD with AI-R (p=0.0047). The proportion of patients in clinical and endoscopic remission at day 182 was higher in PD than in SD (65% vs 36%; p=0.082). Day 182 endoscopic remission with AI-R was higher in PD (52% in PD and 20% in SD; p=0.0337). SAEs occurred in 9% of patients on PD vs 20% of patients on SD. Following an interim analysis, the trial was discontinued based on futility.

Table 1. Baseline characteristics

	Personalised treatment (n=23)	Standard treatment (n=25)
Gender = Male (%)	11 (47.8)	15 (60.0)
Age (year) (median [IQR])	37.00 [24.50, 57.50]	42.00 [30.00, 56.00]
Disease duration (years) (median [IQR])	1.75 [0.62, 5.30]	6.16 [2.61, 17.21]
Naive to advanced therapy (%)	18 (78.3)	21 (84.0)
Lichtiger score (median [IQR])	14 [13, 16]	14 [12, 15]
Total Mayo score (median [IQR])	11 [11, 11]	11 [10, 11]
UCEIS (median [IQR])	6 [5, 7]	6 [5, 7]
CRP (mg/L) (median [IQR])	49.00 [35.70, 70.30]	51.00 [17.00, 105.00]
Albumin (g/L) (median [IQR])	26.00 [23.00, 30.50]	31.00 [23.00, 34.00]

Advanced therapy was defined as treatment with any biologics, JAK inhibitor or S1P modulator. IQR = interquartile range; UCEIS = Ulcerative Colitis Endoscopic Index of Severity, CRP = C-reactive protein.

Conclusion

Personalised IFX dosing was superior to standard dosing in ASUC when endoscopies were read by AI. This is the first IBD study where the primary endpoint, missed by expert assessment, was overturned and met by AI assessment instead. This demonstrates the potential of AI to fundamentally improve clinical trial methodology.

References

1. Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010;59(1):49-54.
2. Papamichael K, Van Stappen T, Vande Casteele N, Gils A, Billiet T, Tops S, et al. Infliximab Concentration Thresholds During Induction Therapy Are Associated With Short-term Mucosal Healing in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2016;14(4):543-9.
3. Ungar B, Mazor Y, Weisshof R, Yanai H, Ron Y, Goren I, et al. Induction infliximab levels among patients with acute severe ulcerative colitis compared with patients with moderately severe ulcerative colitis. Aliment Pharmacol Ther. 2016;43(12):1293-9.
4. Byrne M, Requa J, Panaccione R, Panes J, Bressler B, East JE, et al. Development and Validation of a novel AI-based computer vision solution for Ulcerative Colitis severity scoring on video for real world using high-volume expert-annotated video frames. United European Gastroenterol J. 2025 Oct.

Disclosure

This project received grant support from Pfizer Inc. and research support from Baysient LLC, Buhlmann Laboratories and Dova Health Intelligence.

Event

UEG Week Berlin 2025

Topics

Endoscopy IBD Mechanisms & Personalised Medicine

Submission format

Late-Breaking Abstract

Session

Hot off the press: IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

Appendectomy? The solution for ulcerative colitis

Eva Visser

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LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Ian White

UEG Presentation

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Fistulising Crohn's disease: Underlying mechanism

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Fistulising Crohn's disease: Underlying mechanism

Judy Chou 1

Affiliations

1 Icahn School of Medicine at Mount Sinai, New York, United States of America

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Primary Care Surgery

Session

Disease primer: From inflammation to restoration - wound healing in IBD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

Appendectomy? The solution for ulcerative colitis

Eva Visser

Optimising success in IBD treatment: Timing surgery and medical treatment

Wilhelmus A. Bemelman

The pregnant IBD patient (Complete Session)

LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Ian White

UEG Presentation

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Appendectomy? The solution for ulcerative colitis

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Appendectomy? The solution for ulcerative colitis

Eva Visser 1

Affiliations

1 Amsterdam University Medical Centre, Amsterdam, Netherlands

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Paediatrics Surgery

Session

What's new in ulcerative colitis 2025?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

Appendectomy? The solution for ulcerative colitis

Eva Visser

Optimising success in IBD treatment: Timing surgery and medical treatment

Wilhelmus A. Bemelman

The pregnant IBD patient (Complete Session)

LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Ian White

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

Optimising success in IBD treatment: Timing surgery and medical treatment

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Optimising success in IBD treatment: Timing surgery and medical treatment

Wilhelmus A. Bemelman 1, Hannah Gordon 2

Affiliations

1 Academisch Medisch centrum Dept. of Surgery - Department of Surgery, Academisch Medisch centrum Dept, Amsterdam, Netherlands

2 Royal London Hospital, London, United Kingdom

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Abstract

Event

UEG Week Berlin 2025

Session

How to optimise success in IBD treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

Appendectomy? The solution for ulcerative colitis

Eva Visser

Optimising success in IBD treatment: Timing surgery and medical treatment

Wilhelmus A. Bemelman

The pregnant IBD patient (Complete Session)

LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Ian White

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

The pregnant IBD patient (Complete Session)

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The pregnant IBD patient (Complete Session)

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Abstract

Event

UEG Week Berlin 2025

Topics

IBD Paediatrics

Session

The pregnant IBD patient

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

ARTIFICIAL INTELLIGENCE ENDOSCOPY SCORING DEMONSTRATES THAT TDM-BASED INFLIXIMAB DOSE-INTENSIFICATION IS SUPERIOR TO STANDARD DOSING IN PATIENTS WITH ACUTE SEVERE ULCERATIVE COLITIS: A POST-HOC ANALYSIS OF THE TITRATE STUDY

Peter Irving

Fistulising Crohn's disease: Underlying mechanism

Judy Chou

Appendectomy? The solution for ulcerative colitis

Eva Visser

Optimising success in IBD treatment: Timing surgery and medical treatment

Wilhelmus A. Bemelman

The pregnant IBD patient (Complete Session)

LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Ian White

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

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LONG-TERM OUTCOMES OF CUFFITIS IN PATIENTS AFTER TOTAL PROCTOCOLECTOMY WITH ILEAL POUCH-ANAL ANASTOMOSIS DUE TO ULCERATIVE COLITIS

Maya Fischman 1, Michal Codish 2, Revital Barkan 3, Ian White 4, Nir Wasserberg 4, Keren M Rabinowitz 5, Tom Konikoff 5, Irit Avni-Biron 5, Hagar Banai Eran 5, Yifat Snir 5, Henit Yanai 3, Lihi Godny 4, Iris Dotan 4, Jacob E. Ollech 4

Affiliations

1 Rabin Medical Center, Petah Tikva, Israel|||Hebrew University of Jerusalem, Jerusalem, Israel

2 Tel Aviv University, Tel Aviv, Israel

3 Rabin Medical Center, Petah Tikva, Israel|||Tel Aviv University, Tel Aviv, Israel

4 Tel Aviv University, Tel Aviv, Israel|||Rabin Medical Center, Petah Tikva, Israel

5 Rabin Medical Center, Petah Tikva, Israel

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Abstract

Introduction

In patients with ulcerative colitis (UC), total proctocolectomy with restorative ileal pouch-anal anastomosis (IPAA) is a definitive surgical treatment for refractory disease or colorectal dysplasia. A short rectal cuff is typically retained and anastomosed to the pouch, and may become inflamed over time, a condition referred to as cuffitis. The clinical relevance of cuffitis remain unexplored. In this study, we aimed to characterize the long-term disease course associated with histologic cuffitis.

Aims & Methods

Patients with UC who underwent total proctocolectomy and IPAA were prospectively followed in a comprehensive pouch clinic at a tertiary referral center for patients with inflammatory bowel diseases (IBD). We included all patients who underwent at least one pouch endoscopy with paired pouch and cuff biopsies between 2017 and 2024. Cuffitis was defined as a NANCY Index histologic score of 3-4, and pouchitis was defined as histologic subscore of PDAI³2. Outcomes assessed included documented inflammatory pouch flares, defined by clinical evaluation; antibiotics used due to pouch inflammation; and initiation of biologics. Associations were evaluated using Poisson regression to estimate incidence rate ratios (IRRs) and Fisher’s exact test for categorical comparisons.

Results

A total of 116 patients underwent 250 pouch endoscopies during the study period. Average age of the cohort was 50.4 (±14.9) and 59% were females. Histologic pouchitis was detected in 80 (68.9%), and cuffitis in 76 (65.5%) patients. Most patients had extensive disease prior to IPAA (n=105, 90.5%) and indication for surgery was refractory UC (n=94, 81.0%). Concurrent pouchitis and cuffitis were identified in 54 (46.5%) patients. Patients with histologic-proven cuffitis had a significantly higher incidence rate of subsequent disease flares(IRR 4.39, 95% CI: 2.26-9.86, p<0.001) and required more antibiotic courses (IRR 1.94, 95% CI: 1.11-3.62, p=0.027) compared to those who never developed cuffitis. These associations remained significant after adjusting for the presence of histologic pouchitis. No significant difference was observed in the initiation of biologics (p=0.81). Among patients with at least two endoscopies during follow-up and isolated cuffitis at baseline (n=61), 6 patients with isolated cuffitis further developed new-onset pouchitis, while 15 patients with isolated pouchitis subsequently developed cuffitis. The remaining 40 patients (65.5%) maintained the same inflammatory pattern over time.

Conclusion

Histologic-proven cuffitis is independently associated with adverse long-term outcomes in patients post-IPAA, including flares and repeated antibiotic use, even in the absence of pouchitis. The persistence of inflammation in the retained rectal cuff, representing a remnant of the previously diseased colonic mucosa, raises mechanistic questions about its potential role in modulating inflammatory activity of the pouch. These findings emphasize the clinical importance of evaluating the rectal cuff in patients post-IPAA. Routine histologic assessment of the cuff should be incorporated into post IPAA surveillance, and interventional studies are warranted to determine whether targeted treatment of cuffitis can mitigate pouch related morbidity.

Disclosure

Jacob E Ollech: Has received grant support from Pfizer, consulting fees from Takeda, and
speaker fees from Abbvie, Janssen, Pfizer, Takeda, Novartis, and Bristol Myers Squibb.
Iris Dotan: consultation fee or honorarium from: Abbott, Abbvie, Athos, Arena, Altman
Research, Cambridge Healthcare, Celltrion, Celgene/BMS, Eli-Lilly, Ferring, Falk Pharma, Food
Industries Organization, Gilead, Galapagos, Iterative Scopes, Integra Holdings, Janssen,
Neopharm, Pfizer, Rafa laboratories, Roche/Genentech, Sangamo, Sublimity, Sandoz, Takeda,
Wildbio. Grants: Altman Research, BMS, Pfizer

Event

UEG Week Berlin 2025

Topics

Colorectal Endoscopy Surgery IBD

Submission format

Abstract

Session

Lower GI: Surgical considerations

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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